NCT00122226|UnknownPhase 4
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Sponsor study identifier
interventional
50
4 countries
13
Study Start
January 2003
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
Not reported
Date not reportedStudy Completion
July 2008
Date type not reportedThis date has not been verified as actual or estimated.
This is a randomized prospective study into metabolic adverse events during different types of initial antiretroviral therapy in HIV-1-infected men.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 2008
Date type not reportedThis date has not been verified as actual or estimated.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 2003
Date type not reportedThis date has not been verified as actual or estimated.
July 14, 2005
Actual (reported)July 21, 2005
Actual (reported)July 2008
Date type not reportedThis date has not been verified as actual or estimated.
insulin resistance (3, 12, 24, 36 months)
microvascular function (3, 12, 24, 36 months)
lipid profile (3, 12, 24, 36 months)
body composition (3, 12, 24, 36 months)
macrovascular function (12, 24, 36 months)
mitochondrial DNA in PBMC and fatty tissue (12, 24, 36 months)
gene expression, markers of mitochondrial toxicity, inflammation, apoptosis, fat cell differentiation in fatty tissue (12, 24, 36 months)
bone mineral density (12, 24, 36 months)
natural killer cells (3, 12, 24 months)
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
Grouped treatment entry
Lopinavir/ritonavir + zidovudine + lamivudine
The registry names several treatments. This does not confirm that participants received them together or that they form a single product.
View registry recordGrouped treatment entry
Lopinavir/ritonavir + nevirapine
The registry names several treatments. This does not confirm that participants received them together or that they form a single product.
View registry recordHelsinki University Central Hospital
Helsinki, Finland
Academic Medical Center
Amsterdam, Netherlands
Medisch Centrum Jan van Goyen
Amsterdam, Netherlands
Onze Lieve Vrouwe Gasthuis, location Oosterpark
Amsterdam, Netherlands
Onze Lieve Vrouwe Gasthuis, location Prinsengracht
Amsterdam, Netherlands
Slotervaart ziekenhuis
Amsterdam, Netherlands
VUMC Free University Medical Center
Amsterdam, Netherlands
van Vonderen MG, Blumer RM, Hassink EA, Sutinen J, Ackermans MT, van Agtmael MA, Yki-Jarvinen H, Danner SA, Serlie MJ, Sauerwein HP, Reiss P. Insulin sensitivity in multiple pathways is differently affected during zidovudine/lamivudine-containing compared with NRTI-sparing combination antiretroviral therapy. J Acquir Immune Defic Syndr. 2010 Feb;53(2):186-93. doi: 10.1097/QAI.0b013e3181c190f4.
van Vonderen MG, van Agtmael MA, Hassink EA, Milinkovic A, Brinkman K, Geerlings SE, Ristola M, van Eeden A, Danner SA, Reiss P; MEDICLAS study group. Zidovudine/lamivudine for HIV-1 infection contributes to limb fat loss. PLoS One. 2009 May 21;4(5):e5647. doi: 10.1371/journal.pone.0005647.
S. A. Danner, MD, PhD
Universitair Ziekenhuis Brussel
P. Reiss, MD, PhD
Academic Medical Center, National AIDS Therapy Evaluation Centre
First Submitted
July 14, 2005
First Posted
July 21, 2005
Study Start
January 2003
Date type not reportedThis date has not been verified as actual or estimated.
Study Completion
July 2008
Date type not reportedContact the study team to confirm eligibility.
Kennemer Gasthuis, location Elisabeth
Haarlem, Netherlands
Leids Universitair Medisch Centrum
Leiden, Netherlands
Erasmus Universitair Medisch Centrum
Rotterdam, Netherlands
Ziekenhuis Leyenburg
The Hague, Netherlands
Hospital Clinic
Barcelona, Spain
Royal Free Hospital
London, United Kingdom
van Vonderen MG, Lips P, van Agtmael MA, Hassink EA, Brinkman K, Geerlings SE, Sutinen J, Ristola M, Danner SA, Reiss P. First line zidovudine/lamivudine/lopinavir/ritonavir leads to greater bone loss compared to nevirapine/lopinavir/ritonavir. AIDS. 2009 Jul 17;23(11):1367-76. doi: 10.1097/QAD.0b013e32832c4947.
van Vonderen MG, Hassink EA, van Agtmael MA, Stehouwer CD, Danner SA, Reiss P, Smulders Y. Increase in carotid artery intima-media thickness and arterial stiffness but improvement in several markers of endothelial function after initiation of antiretroviral therapy. J Infect Dis. 2009 Apr 15;199(8):1186-94. doi: 10.1086/597475.
This date has not been verified as actual or estimated.
Last Updated
April 25, 2006
Record last verified: 2005-07
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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